Clinical Lab Research Specialist - In Vitro Diagnostics

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 125,000 - 135,000; Full time

Job summary

MillenniumSoft Inc seeks a Clinical Lab Research Specialist to join our Franklin Lakes, NJ team on a 12-month contract. The role supports design, evaluation, execution and reporting for in-vitro diagnostic devices, leveraging expertise across phlebotomy, chemistry, hematology, and LIS/LIMS systems.

You will manage studies, ensure quality and collaborate with R&D and regulatory units. Ideal candidates hold a BS/BA/MA in Clinical Laboratory Science or Medical Technology, MT/MLT CLS (ASCP) or

Qualifications

• BS/BA/MA in Clinical Laboratory Science or Medical Technology is required.
• MT/MLT CLS (ASCP) or equivalent experience in a Research environment.
• 5+ years experience in the Clinical Laboratory environment.

Responsibilities

• Provides input to design, evaluation, execution and reporting for safety and efficacy of IVDDs and related devices.
• Conducts clinical testing and maintains laboratory instrumentation and inventory.
• Implements and documents Quality Assurance and Quality Control procedures for instrumentation and methods.
• Performs instrument verification per CLSI guidelines and ensures GLP/GCP compliance.
• Keeps current with literature, continuing education and cross-functional collaboration.
• Manages clinical studies and investigates customer complaints through clinical investigations.

Skills

Clinical laboratory science

Communication skills

GCP/GLP/ISO regulations

Phlebotomy

Blood collection products

Troubleshooting

Computer skills

Project planning & budgeting

LIS/LIMS knowledge

R&D collaboration

Education

BS/BA/MA in Clinical Laboratory Science or Medical Technology

MT/MLT CLS (ASCP) or equivalent

5+ years in Clinical Laboratory environment

Job description

MillenniumSoft Inc seeks a Clinical Lab Research Specialist to join our Franklin Lakes, NJ team on a 12-month contract. The role supports design, evaluation, execution and reporting for in-vitro diagnostic devices, leveraging expertise across phlebotomy, chemistry, hematology, and LIS/LIMS systems.

You will manage studies, ensure quality and collaborate with R&D and regulatory units. Ideal candidates hold a BS/BA/MA in Clinical Laboratory Science or Medical Technology, MT/MLT CLS (ASCP) or